There is no FDA-licensed lab test for XMRV, and officials say they are still setting standards for diagnosing it.

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This sounds fairly unambiguous.

The federal working group's project has three phases. First, labs at six participants—including the FDA, the National Cancer Institute, the CDC, and the Whittemore Peterson lab—are using a panel of blood samples to try to establish which of the labs' tests are sensitive and reliable enough to find XMRV in the blood. Results are expected in a few weeks.

In the second phase, also launched, a panel of around 350 different blood samples developed by Dr. Busch's team will be sent to four different labs. Some of the samples are from chronic fatigue patients known to have XMRV. Others from healthy donors have been spiked with the virus or have tested negative. All the samples are blinded, and the study will see whether the different labs can agree on XMRV positive status for chronic fatigue patients.

A third phase may be launched later, using frozen specimens in federal repositories dating to the 1970s. These repositories link donors to recipients and will allow researchers to see if XMRV was transferred in transfusions and help determine prevalence in the past as well as today, as well as geographical clusters or associations with age and gender.

Potential Risk to Blood Supply Probed
XMRV Virus Gets Attention of Health Officials, but It's Unclear if There Is Any Danger
By AMY DOCKSER MARCUS

An infectious virus linked to two diseases is drawing the attention of public-health officials, who are investigating the potential threat to the nation's blood supply.

It isn't clear if the virus, known as XMRV, poses a danger, and public-health officials say there isn't evidence of spreading infection. But because of concern over the potential for widespread infection and preliminary evidence that XMRV is transmitted similarly to HIV, officials are quickly trying to determine if action is needed to protect the blood supply.

XMRV was discovered in 2006 when it was found in tumor samples from men with a rare form of familial prostate cancer. Research has also linked the virus to chronic fatigue syndrome and found it in measurable levels in the blood of healthy people. But the evidence isn't conclusive, as several other studies failed to find XMRV in the blood of people with chronic fatigue syndrome, and it isn't known how prevalent the virus is or whether it causes disease.

"These are early days trying to understand the public health significance of XMRV," said Jay Epstein, director of the Office of Blood Research and Review at the Food and Drug Administration.

Efforts are under way to find effective tests for the virus and determine its prevalence, led by a working group funded by the National Institutes of Health and including federal agencies such as the FDA and the Centers for Disease Control and Prevention. Blood banks, academic institutions and at least one advocacy group are also involved.

The focus on XMRV is part of a growing effort to better monitor emerging infectionsdisorders that have either increased in humans in recent decades or are deemed a potential threat. Currently there are 12 tests used to block infectious agents from entering the blood supply, such as HIV or hepatitis C, and more screens are under study, including those for dengue, human variant Creutzfeldt-Jakob disease and agents that cause malaria. There is no FDA-licensed lab test for XMRV, and officials say they are still setting standards for diagnosing it.

Public-health officials increasingly recognize that even infections not typically found in the U.S. can quickly come here because of global travel. Many viruses also have long incubation periods, making it harder to recognize that the virus was transmitted by a blood transfusion. In an October 2009 report, a federal advisory committee on blood safety and availability concluded that biovigilance in the U.S. is a "patchwork of activities, not a cohesive national program."

The incidence of infectious diseases being transmitted through transfusions is small, typically only a handful each year, according to the American Red Cross and data reported to the FDA. About 16 million units of whole blood and red blood cells were donated in the U.S. in 2006, the latest data available, according to the 2007 National Blood Collection and Utilization Report. The American Red Cross, which collects almost half of blood donations in the U.S., estimated that about 10,000 donors a year turn out to be infected with pathogens that officials screen for. Nearly half are hepatitis C virus.

Michael P. Busch, who runs the Blood Systems Research Institute in San Francisco and is a member of the XMRV working group, notes that everyone harbors benign viral infections. These viruses are transmitted in every blood transfusion, but aren't known to cause diseases in recipients, says Dr. Busch. Even if XMRV is found to be present in large numbers of blood donors, Dr. Busch notes, it is still necessary to determine if XMRV causes diseases.

The working group was established after a paper was published in October in the journal Science, where researchers reported finding the virus in a majority of 101 patients with chronic fatigue syndrome. The study's co-authors at the Whittemore Peterson Institute for Neuro-Immune Disease, the National Cancer Institute and the Cleveland Clinic,also found the virus in nearly 4% of 218 healthy people used as controls in the study.

Extrapolating from those numbers, public-health officials estimated that up to 10 million people in the U.S. and hundreds of millions of people globally could be infected with XMRV, or xenotropic murine leukemia virus-related virus.

The apparent link to CFS, which affects an estimated 17 million people world-wide, and has no specific treatments, has been closely followed by the patient advocacy community. The Whittemore Peterson institute, established by the family of a chronic fatigue patient, has started collecting blood from CFS patients who got their diagnosis following a blood transfusion and plan to launch their own study of the issue, says Annette Whittemore, founder and president of the institute.

The CFIDS Association of America, an advocacy group for chronic fatigue syndrome, set up a bank to collect biospecimens to be used in potential studies about CFS, including XMRV-related ones. Researchers at Emory University and the University of Utah published a study last week showing that XMRV may be treatable with drugs that treat HIV.

The AABB, an association of facilities that collect virtually all of the U.S. blood supply, has also set up an XMRV task force, although the virus doesn't appear on a list of infectious agents evaluated by a special AABB transfusion-risk committee, as concerns came out after the latest list was put together.

Labs in Europe reported earlier this year that they haven't been able to replicate the XMRV findings in patients with chronic fatigue syndrome or prostate cancer. And public-health experts say a key issue in sorting out the disparate findings is to reach agreement on tests that are sensitive and reliable in identifying XMRV in the blood.

The federal working group's project has three phases. First, labs at six participantsincluding the FDA, the National Cancer Institute, the CDC, and the Whittemore Peterson labare using a panel of blood samples to try to establish which of the labs' tests are sensitive and reliable enough to find XMRV in the blood. Results are expected in a few weeks.

In the second phase, also launched, a panel of around 350 different blood samples developed by Dr. Busch's team will be sent to four different labs. Some of the samples are from chronic fatigue patients known to have XMRV. Others from healthy donors have been spiked with the virus or have tested negative. All the samples are blinded, and the study will see whether the different labs can agree on XMRV positive status for chronic fatigue patients.

A third phase may be launched later, using frozen specimens in federal repositories dating to the 1970s. These repositories link donors to recipients and will allow researchers to see if XMRV was transferred in transfusions and help determine prevalence in the past as well as today, as well as geographical clusters or associations with age and gender.

"There is a balance to what we are doing," says Simone A. Glynn, branch chief of transfusion medicine and cellular therapies at the National Heart, Lung and Blood Institute and chairperson of the XMRV working group. "You do not want to transfuse an infectious agent that causes problems. But you do not want to take blood out of the system that is not causing any problems."

The federal working group's project has three phases. First, labs at six participants—including the FDA, the National Cancer Institute, the CDC, and the Whittemore Peterson lab—are using a panel of blood samples to try to establish which of the labs' tests are sensitive and reliable enough to find XMRV in the blood. Results are expected in a few weeks.

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ALSO

All the samples are blinded, and the study will see whether the different labs can agree on XMRV positive status for chronic fatigue patients.

The federal working group's project has three phases. First, labs at six participants—including the FDA, the National Cancer Institute, the CDC, and the Whittemore Peterson lab—are using a panel of blood samples to try to establish which of the labs' tests are sensitive and reliable enough to find XMRV in the blood. Results are expected in a few weeks.

In the second phase, also launched, a panel of around 350 different blood samples developed by Dr. Busch's team will be sent to four different labs. Some of the samples are from chronic fatigue patients known to have XMRV. Others from healthy donors have been spiked with the virus or have tested negative. All the samples are blinded, and the study will see whether the different labs can agree on XMRV positive status for chronic fatigue patients.

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Well, tail wags all around! Thank goodness we will get some new news shortly and it looks like we will finally get our blinded study. In the sausage grinder of science, we've finaly slaughtered the pig.

In the second phase, also launched, a panel of around 350 different blood samples developed by Dr. Busch's team will be sent to four different labs. Some of the samples are from chronic fatigue patients known to have XMRV. Others from healthy donors have been spiked with the virus or have tested negative. All the samples are blinded, and the study will see whether the different labs can agree on XMRV positive status for chronic fatigue patients.

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Robin, I loved your post. I think there is a LOT to be excited about. I still can't get over the matter of fact way that prostate cancer and chronic fatigue syndrome are said in the same breath as if, of course, ME/CFS is a REAL disease!

So, sorry to move on, but I just have to ask.

Am I the only one just a tab bit worried about this?

Do we know enough about Dr. Busch and the labs he will be using? And the testing method being used? (I have been told that Panorama, the lab doing the second study I am involved in, has been having trouble finding XMRV and are waiting before trying again.)

This is not to say that I doubt the existence of XMRV (I think it is beyond dispute that it exists), nor do I have reason to doubt that XMRV has been shown to be strongly associated with ME/CFS. I just don't trust other labs at this time. I don't see that any of them (other than WPI and VIP) have gotten it right about finding XMRV in blood samples (there was the one unpublished report from Japan). I'm worried that if this trial fails, it will set us back big time.

I thought I had posted this on this site but it was on another site (PLM aka www.patientslikeme.com)! Great to see islandfinn saw the news as well. I've been following it for some time since my work includes Blood Bank.

Interesting how little press XMRV has gotten given the possible transmission in the blood supply. The AABB (American Association of Blood Banks) has had a Task Force in place. See below:

AABB Statement on XMRV Task Force

February 17, 2010

AABB recently convened an Interorganizational Task Force on Xenotropic Murine Leukemia Virus-Related Virus (XMRV). The Task Force is charged with reviewing the available data on the potential transmission of XMRV through blood transfusion, making recommendations for further action to assess the risk of transmission and developing appropriate messages for donors, recipients, and the public. The Task Force includes representatives from the blood community, patient advocacy representatives, XMRV subject matter experts and liaisons from several government agencies, including the Office of the Assistant Secretary for Health, the Centers for Disease Control and Prevention, and the Food and Drug Administration. Dr. Harvey Klein, Chief of the Department of Transfusion Medicine, National Institutes of Health Clinical Center, serves as the task force chair.

Currently there are insufficient data about the potential transmissibility of XMRV through blood transfusion or the relationship of the virus to any disease or syndrome. Background information about XMRV and its characteristics that specifically relate to potential transfusion transmissibility can be found in the AABB XMRV Fact Sheet, published by the Transfusion Transmitted Diseases (TTD) Committee in January 2010. This fact sheet is an addition to the 68 fact sheets on emerging infectious disease agents prepared by the TTD Committee and published in the August 2009 Supplement to Transfusion.

The Task Force will examine new data concerning the potential transmission of this virus as they become available in the next months and update information contained in the fact sheet as necessary. At present, there are no specific recommendations regarding deferral of individuals with diseases or syndromes that have been linked to XMRV, although such donors would be deferred if, on the day of donation, they respond negatively to the question, Are you feeling well today?

CFS organizations..at least in my state.. have suggested that individuals with ME/CFS not donate blood. DUH!

In the second phase, also launched, a panel of around 350 different blood samples developed by Dr. Busch's team will be sent to four different labs. SOME OF THE SAMPLES ARE FROM CHRONIC FATIGUE PATIENTS KNOWN TO HAVE XMRV. Others from healthy donors have been spiked with the virus or have tested negative. All the samples are blinded, and the study will see whether the different labs can agree on XMRV positive status for chronic fatigue patients.

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That's the 2nd time in a week that I've seen a major player say they are using positive controls from the Science study. The other player - that two-bit pharma tiny pharma company: Glaxo Smith Kline.

So, can we put some more garbage science to rest?
How about those pesky statements that:

XMRV isn't a virus

XMRV isn't found in CFS patients

WPI's work was all contaminated

Please don't jump all over me. I know that ALL scientists can be fallible, and that we need to scrutinize all science. But come on. Was there ever any comparison between the junk across the pond, and the Science work?

It isn't clear if the virus, known as XMRV, poses a danger, and public-health officials say there isn't evidence of spreading infection.

But the evidence isn't conclusive, as several other studies failed to find XMRV in the blood of people with chronic fatigue syndrome, and it isn't known how prevalent the virus is or whether it causes disease.

The focus on XMRV is part of a growing effort to better monitor emerging infections...

Public-health officials increasingly recognize that even infections not typically found in the U.S. can quickly come here because of global travel. Many viruses also have long incubation periods, making it harder to recognize that the virus was transmitted by a blood transfusion.

The incidence of infectious diseases being transmitted through transfusions is small, typically only a handful each year, according to the American Red Cross and data reported to the FDA.

Michael P. Busch, who runs the Blood Systems Research Institute in San Francisco and is a member of the XMRV working group, notes that everyone harbors benign viral infections.

"There is a balance to what we are doing," ...... "You do not want to transfuse an infectious agent that causes problems. But you do not want to take blood out of the system that is not causing any problems."

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Notwithstanding the following:

"In an October 2009 report, a federal advisory committee on blood safety and availability concluded that biovigilance in the U.S. is a "patchwork of activities, not a cohesive national program." "

And the ultimate in bureaucratic avoidance tactics.

"The AABB, an association of facilities that collect virtually all of the U.S. blood supply, has also set up an XMRV task force, although the virus doesn't appear on a list of infectious agents evaluated by a special AABB transfusion-risk committee, as concerns came out after the latest list was put together."

This is what jumped out at me: That's the 2nd time in a week that I've seen a major player say they are using positive controls from the Science study.

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Parvo my friend, Do we know that the positive XMRV folks came from the Science study? There is a second cohort (and soon there may be at least a third) of positive XMRV patients. Just wondering if you knew these positives were from the WPI. Don't mean to sound picky, just wondering if I overlooked something.

This is brilliant news. I've been waiting for them to do something like this for the last six months.

The WPI's claims about XMRV are going to be tested in a serious way, and if they hold up, everyone will have to recognise that they've found something massively important. If not - at least we'll know.

To many major "players" are converging on this for it not to be real. To many of the people involved are going back for second funding to bigger studies for this not to be traveling down the road to causation. Paul Jolicoure in Canada asking for more funding and planning to present at the next CROI at the end of this month. The Dr.'s Light spending money they were going to used to market their CFS bio-marker test on additional XMRV testing. GSK doing what looks to be a "pure" replication study. Six different labs working to produce a serology test. The rush by big Pharma to test drugs against the virus so that they'll be positioned to hit the market as soon as "proof" is published.

It's a little overwhelming. (grins) and who would of thunk it that; we'd even know about "CROI's" and "Neurtralizing" and other cool words and acronyms this time last year? Gotta love the ride even if it makes you throw up sometimes!!!!

CFS patients known to have XMRV from the Science paper used as positive control

Hi CBS - a good question, with important implications for XMRV in general. I had to go by memory to try to find the source. Here's the one for GSK from the thread: http://www.forums.aboutmecfs.org/showthread.php?4066-New-XMRV-study-to-be-undertaken.&highlight=glaxo+smith+kline

To help resolve this quandary, Glaxo Smith Kline, a pharmaceutical firm in Research Triangle Park, NC, has funded a new study that will evaluate CFS patients with characteristics similar to the Science paper. CFS patients known to have XMRV from the Science paper will be used as a positive control. This study is designed to estimate the prevalence of XMRV in CFS subjects (selected by the modified Fukuda criteria and the Canadian criteria) and healthy control subjects.
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CBS, I think this is HUGE. Pharma giant GSK trusts the Science results sufficiently to use their positive controls. I believe GSK - being who they are - would have clearly looked for more corroboration - that may well still be in the pipeline. But they're not only confident enough to use positive controls from the Science team - they also go public with their study. That is HUGE! Will try to do some more memory digging....

To many major "players" are converging on this for it not to be real. To many of the people involved are going back for second funding to bigger studies for this not to be traveling down the road to causation. Paul Jolicoure in Canada asking for more funding and planning to present at the next CROI at the end of this month. The Dr.'s Light spending money they were going to used to market their CFS bio-marker test on additional XMRV testing. GSK doing what looks to be a "pure" replication study. Six different labs working to produce a serology test. The rush by big Pharma to test drugs against the virus so that they'll be positioned to hit the market as soon as "proof" is published.

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Also the fact that increasing #'s of prostate cancer researchers are crossing over to the "dark side" (ME/CFS) and doing research here. Dr Singh really has her finger on several pulses - and is forging full speed ahead looking already into drugs to treat XMRV in vitro. Those 45 compounds and 28 drugs really got me thinking - would they do that if they profoundly doubted XMRV as causal? Lots of good news.

Can Passenger Viruses be Pathogenic?
But perhaps there's another angle. Even if XMRV is a "passenger virus", it may well be pathogenic in its own right too. (Or is that an oxymoron?) That virulence and immunosuppressive factor on the XMRV envelope. The virulent protein particles expressed. The ability to rev up other opportunistic infections. Or is a passenger virus always benign? Someone help me out here? Either way, given what we have learned so far about XMRV, it sounds like you need to do something treatmentwise because XMRV - even if it isn't the Grand Poohbah - stirs up a heck of trouble that can't be ignored, and that appears to significantly contribute to morbidity. And that's one more step toward more comprehensive treatment for ME/CFS.

Tho my personal belief: I think the writing's appearing on that wall that XMRV is "it", & we're just going through formalities now.